1. Field of the Invention
The present invention relates to an improved orthotic particularly arranged and adapted to be made by a relatively convenient and rapid process or method, and also to the method of making the orthotic.
2. Background Art
An orthotic insert can be either soft or hard. A hard insert is a substantially rigid member, desirably having a relatively thin vertical thickness dimension and extending from the calcaneus area of the foot (the heel portion) to at least the metatarsal head area of the foot (i.e. that area at the "ball" of the foot). In general, the purpose of a rigid orthotic (sometimes called a functional orthotic) is to first position, and then to control the movements of, the midtarsal and subtalar joints during the gait cycle which the body goes through in walking and running, and also possibly for other movements.
A common method of making an orthotic insert is first to prepare a negative mold of a person's foot, such as a plaster of paris mold. One desirable way of accomplishing this is described in U.S. Pat. No. 3,995,002, entitled "Orthocasting System", the inventor being the same as the applicant herein. In that method, a moldable material is placed against the bottom of the person's foot, and a flexible plastic bag is placed around the moldable material and the person's foot, so as to extend upwardly around the person's ankle. Further, a suction hose is placed within the bag so that the inlet to the hose is positioned on the upper part of a person's foot. A vacuum is applied to cause atmospheric pressure to press against the bag and also press the moldable material upwardly against the plantar surface (i.e. bottom surface) of the person's foot, and also a short distance upwardly around the side of the person's foot. The operator properly positions the person's foot so that the mold is properly formed in the desired configuration. Generally, this will be accomplished by the operator placing the person's foot in the neutral position and manipulating the forward part of the foot so that the midtarsal joint is in the locked or nearly locked position. This may vary somewhat, depending upon individual considerations in making the orthotic.
After the moldable material has hardened to make the mold, the plastic bag and the mold are removed. Then a positive cast is made from the mold (this generally being a plaster of paris cast, the contours of which correspond to the person's foot). From this positive cast, the orthotic can be made.
It is also known in the prior art to make an orthotic insert by preheating a moldable material, such as a cork-like material, and placing this in a relatively rigid base member having the general contour of a person's foot. The base member and the moldable cork material (which is heated to make it more yielding, and thus moldable) is placed against the person's foot, and the plastic bag is then placed around the base member, the moldable cork material, and the person's foot. A vacuum is applied as described above, and the moldable cork material cools to make the orthotic insert. The base member is removed from the orthotic insert, and this base member can be used again in subsequent molding of an orthotic.
As a modification of the process noted above, instead of using a reusable base member, which does not become part of the orthotic, a relatively rigid cap can be utilized, with this cap becoming part of the finished orthotic. In this particular method, the moldable cork-like material is placed within the cap, along with an upper yielding blank, and in the preferred embodiment an intermediate flexible member. The cork-like material is heated so as to be yielding and thus moldable, and the cap can also be heated, primarily to keep the cork-like material at an adequately high temperature during the forming process. Then the vacuum bag is applied and the vacuum imposed, as described above. The components are then permitted to cool, with the cap, the cork material, the flexible blank and the flexible insert forming the finished orthotic. Such a procedure is described in pending U.S. Pat. application Ser. No. 766,049, entitled "Improved Orthotic Insert and Method of Making the Same", the inventor being the same as the applicant herein.
To turn our attention now to other aspects relevant to the background of the present invention, there will now be a discussion of the following: (a) the main components or parts of the human leg and foot and how these function relative to one another; b) the gait cycle which a person goes through in a normal walking motion; and (c) the intended function of a rigid orthotic in optimizing the coordinated operation of the person's foot and leg throughout the gait cycle.
For convenience, these various topics will be discussed under appropriate subheadings.
(a) The Main Components or Parts of the Human Leg and Foot and How These Function Relative to One Another PA1 (b) The Gate Cycle Which the Person Goes Through in a Normal Walking Motion PA1 (c) The Intended Function of the Orthotic to Improve Operation of the Person's Foot and Leg Throughout the Gait Cycle
With reference to FIGS. 1-3, there is shown a typical human foot 10, and (in FIGS. 2 and 3) the lower part 12 of the leg 14. The two lower bones of the leg 14 are the tibia 16 and the fibula 18. Below the tibia 16 and fibula 18, there is the talus 20 (i.e. the "ankle bone"). Positioned below and rearwardly of the talus 20 is the calcaneus 22 (i.e. the heel bone). Positioned moderately below and forward of the talus 20 are the navicular 24 and the cuboid 26. Extending forwardly from the navicular 24 are the three cuneform bones 28. Extending forwardly from the cuneform bones 28 and from the cuboid 26 are the five metatarsals 30. Forwardly of the metatarsals 30 are the phalanges 32 which make up the five toes 34.
The movement of the talus 20 relative to the tibia 16 and fibula 18 is such that it enables the entire foot to be articulated upwardly and downwardly (in the motion of raising or lowering the forward part of the foot). However, the talus 20 is connected to the tibia 16 and fibula 18 in such a way that when the entire leg 14 is rotated about its vertical axis (i.e. the axis extending the length of the leg), the talus 20 rotates with the leg 14.
With regard to the relationship of the talus 20 to the calcaneus 22, these move relative to one another about what is called the "subtalar joint" indicated at 36. The subtalar joint 36 can be described generally as a hinge joint about which the talus 20 and calcaneus 22 articulate relative to one another. The hinge axis extends upwardly and forwardly at an angle of about 42.degree. from the horizontal, and also slants forwardly and inwardly at a moderate angle (e.g. about 16.degree. from a straightforward direction). There is also the midtarsal joint 38, and this will be discussed later.
To explain further the hinge motion of the subtalar joint 36, reference is now made to FIGS. 4a and 4b. The talus 20 can be considered as a vertical board 40, and the calcaneus 22 as a horizontally extending board 42, these being hinge connected to one another along a diagonal hinge line 44, with this hinge line corresponding to the subtalar joint 36. It can be seen with reference to FIG. 4a that as the talus 20 is rotated inwardly about its vertical axis (i.e. the front part of the leg being rotated toward the center of the person's body), there is a corresponding rotation of the calcaneus 22 (i.e. the horizontal board 42) about a horizontal axis. It can be seen in FIG. 4b that an opposite (i.e. outward) rotation of the talus 20 (i.e the vertical board 40) causes a corresponding rotation of the calcaneus 22 (i.e. the horizontal board 42) in the opposite direction to that shown in FIG. 4a.
This motion described with reference to FIGS. 4a and 4b above is critical in the gait cycle (i.e. the cycle through which the person goes in normal walking or running motion), and this will be discussed more fully below.
With regard to the midtarsal joint 38, this is in reality composed of two separate joints, the talo-navicular and the calcaneal-cuboid. It is a complex joint, and no attempt will be made to illustrate or recreate its motion accurately. Instead, there will be presented a somewhat simplified explanation of its function as it relates to the present invention.
The main concern, relative to the midtarsal joint, is not the precise relative motion of the parts of the foot that make up this joint, but rather the locking and unlocking mechanism of the midtarsal joint which occurs when there is an outward motion of the leg 14 and the talus 20 (outward motion meaning the rotation of the leg 14 about the vertical axis of the leg 14 in a manner that the knee moves outwardly from the person's body), and an opposite inward motion, respectively. When the leg 14 rotates inwardly, the midtarsal joint 38 unlocks so that the portion of the foot 10 forwardly of the point 38 (i.e. the midfoot 45) is flexible, this being the "pronated" position of the foot. On the other hand, when the leg 14 and talus 20 rotate outwardly, the foot is said to be "supinated" so that the midtarsal joint 38 is locked and the midfoot 45 essentially becomes a part of a rigid lever. In actuality, the midfoot 45 never becomes totally rigid, so that even in the totally supinated position, there is some degree of flexibility in the midfoot 45.
This function of the midtarsal joint will now be explained relative to FIGS. 5a and 5b. It can be seen that FIGS. 5a-b are generally the same as FIGS. 4a-b, except that a forward board member 46 is shown to represent the midfoot 45, this member 46 having a downward taper in a forward direction, and also a lower horizontal plate portion 48. This plate portion 48 is intended to represent that the plantar surface (i.e. the lower support surface) of the midfoot 45 engages the underlying support surface in a manner so as to remain generally horizontal to the support surface.
It can be seen that when the two board members 40 and 42 are in the pronated position of FIG. 5a, the metatarsal joint represented at 50 in FIGS. 5a-b is in a first position which will be presumed to be an unlocked position. In the unlocked position of FIG. 5a, the member 46 is not rigid with the horizontal member 42, and the forward member 46 can flex upwardly relative to the horizontal member 42. (This is the pronated position of the foot 10.) However, in the position of FIG. 5b, the board members 46 and 42 will be presumed to be locked to one another so that the members 42 and 46 form a unitary lever. For ease of illustration, no attempt has been made to illustrate physically the unlocking relationship of FIG. 5a and the locking relationship of FIG. 5b. Rather, the illustrations of FIGS. 5a-b are to show the relative movement of these components, and the locking and unlocking mechanism is presumed to exist.
Reference is first made to FIGS. 6a and 6b. As illustrated in the graph of FIG. 6a, during the normal walking motion, the hip (i.e. the pelvis) moves on a transverse plane, and this movement in the gait cycle is illustrated in FIG. 6b. Also, the femur (i.e. the leg bone between the knee joint and the hip) and the tibia rotate about an axis parallel to the length of the person's leg. (It is this rotation of the leg about its vertical axis which in large part causes the pronating and supinating of the foot during the gait cycle, and this will be explained in more detail below.)
There is also the flexing and extension of the knee, as illustrated in the five figures immediately below the graph of FIG. 6a. Further, there is the flexing and extension of the ankle joint. At the beginning of the gait cycle, the heel of the forwardly positioned leg strikes the ground, after which the forward part of the foot rotates downwardly into ground engagement. After the leg continues through its walking motion to extend rearwardly during the gait cycle, the person pushes off from the ball of the foot as the other leg comes into ground engagement.
The motions described above are in large part generally apparent to a relatively casual observation of a person walking. However, the motion which is generally overlooked by those not familiar with the gait cycle is the inward and outward rotation of the leg about its lengthwise axis to cause the pronating and supinating of the foot through the gait cycle. This will be described relative to FIG. 7a and FIG. 7b.
When the leg is swung forwardly and makes initial ground contact, at the moment of ground contact the leg is rotated moderately to the outside (i.e. the knee of the leg is at a more outward position away from the centerline of the body) so that the foot is more toward the supinated position (i.e. closer to the position shown in FIG. 4b). However, as the person moves further through the gait cycle toward the 25% position shown in FIG. 7a, the leg rotates about its vertical axis in an inside direction so that the subtalar joint is pronating. The effect of this is to rotate the heel of the foot so that the point of pressure or contact moves from an outside rear heel location (shown at 52 in FIG. 7b) toward a location indicated at 54 in FIG. 7b. This pronating of the subtalar joint 36 produces a degree of relaxation of the midtarsal joint 38 and subsequent relaxation of the other stabilization mechanisms within the arch of the foot. This reduces the potential shock that would otherwise be imparted to the foot by the forward part of the foot making ground contact.
With further movement from the 25% to the 75% position, the leg rotates in an opposite direction (i.e., to the outside so that the midtarsal joint 38 becomes supinated at the 75% location of FIG. 7a. This locks the midtarsal joint 38 so that the person is then able to operate his or her foot as a rigid lever so as to raise up onto the ball of the foot and push off as the other leg moves into ground contact at a more forward location.
With reference again to FIG. 7b, the initial pressure at ground contact is at 52 and moves laterally across the heel to the location at 54. Thereafter, the pressure center moves rather quickly along the broken line indicated at 56 toward the ball of the foot. As the person pushes off from the ball of the foot and then to some extent from the toes of the foot, the center of pressure moves to the location at 58.
If the person's foot were perfectly formed, then there would be no need for an orthotic device. However, the feet of most people deviate from the ideal. Accordingly, the function of the orthotic is first to position the plantar surface of the calcaneus 22 and the midfoot 45 so that the subtalar and midtarsal points 36 and 38 are initially positioned properly (i.e., to bring the person's foot back to the ideal functioning position peculiar to the person's foot), and to thus control the subsequent motion of the foot parts or components that make up these joints so that the movements of the hip, leg and foot throughout the gait cycle are properly accomplished. It can be readily understood that if the components of the foot have the proper initial position and movement about the subtalar and midtarsal joints 36 and 38, the entire gait cycle, all the way from the coordinated rotation of the hips through the flexing and rotation of the leg, and also through the initial strike of the heel on the ground to the final push off from the toe of the foot, is properly coordinated and balanced for optimum movement. The only way that the plantar surface of the foot can be controlled is by a three dimensional member conforming to the plantar surface.
Since shoes are generally manufactured on a mass production basis, the supporting surface of the interior of the shoe may or may not optimally locate the plantar surface of the foot. Accordingly, it has for many years been a practice to provide an orthotic insert which fits within the shoe to optimize the locations of the foot components.